Pharmacokinetic interaction between cefaclor and bromhexine in healthy Chinese volunteers

Objective To determine the pharmacokinetic interaction between cefalor and bromhexine in healthy Chinese volunteers. Methods Twelve subjects received a cefaclor (CEF) treatment, a bromhexine (BHX) treatment, and a co-treatment of CEF and BHX with a 3 × 3 Latin square design. The wash-out time between periods was 14 days. The plasma and urine drug concentrations of CEF and BHX were detected by HPLC-UV and LC/MS, respectively. Results AU the 12 volunteers completed the study. There were no significant differences in AUC_0-t, and C_max of CEF in logarithm between the single administration group of CEF and the co - administration group of CEF with BHX. Two one sided t-test showed that CEF was bioequivalent in the 2 groups. There were no significant differences in t_max, MRT, t_1/2, and Cl_r between the 2 groups. V_d/F was significantly lower in the single CEF group than in the co - administration group of CEF and BHX. There were no significant differences of AUC_0-t and C_max of BHX in logarithm between the single administration group of BHX and the co - administration group of BHX with CEF. Two one sided t-test showed that BHX was bioequivalent in the 2 groups. There were no significant differences in t_max, MRT, t _1/2, V_d/F, and Cl_r between the 2 groups. Conclusion There is no significant pharmacokinetic parameter change in the drug absorption, metabolism, and excretion, but V_d/F of CEF significant increases in the co-administration of CEF with BHX. The co-administration of CEF and BHX has no adverse drug interaction. The increase of V_d/F may be a favorable drug interaction, which may be the mechanism of the synergistic effect of the 2 drugs.